Effect of Treatment BI 1744 CL (5 and 10 mcg) Versus Placebo on Exercise Endurance Time During Constant Work Rate Cycle Ergometry I

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Placebo; Drug: Olodaterol (BI 1744); Drug: Olodaterol (BI 1744) Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01040130

1222.37

2009-014395-21 (EudraCT Number)

Details and patient eligibility

About

To compare the effects of BI 1744 CL versus placebo on exercise tolerance after 6 weeks of treatment in patients with Chronic Obstructive Pulmonary Disease

Enrollment: 151 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Signed informed consent prior to participation.
2. Diagnosis of chronic obstructive pulmonary disease and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec) <80% of predicted normal and post-bronchodilator FEV1(Forced Expiratory Volume in 1 sec)/FVC of < 70% at Visit 1.
3. Male or female between 40 and 75 years of age.
4. Current or ex-smokers with smoking history of more than 10-pack years.
5. Able to perform technically acceptable pulmonary function tests, multiple exercise tests and able to maintain records.
6. Able to inhale medication in a competent manner from a metered-dose inhaler and Respimat inhaler.

Exclusion criteria

1. Patients with clinically relevant abnormal baseline haematology, blood chemistry, or urinalysis; all patients with an SGOT >x2 ULN, SGPT >x2 ULN, bilirubin >x2 ULN or creatinine >x2 ULN.
2. Patients with a history of asthma and/or total blood eosinophil count of 600 cells/mm3.
3. Patients with thyrotoxicosis, paroxysmal tachycardia (>100 beats per minute).
4. Patients with a history of myocardial infarction within 1 year of screening visit, unstable or life-threatening cardiac arrhythmia, hospitalization for heart failure within the past year, known active tuberculosis, a malignancy for which patient has undergone resection, radiation therapy or chemotherapy within last five years, life-threatening pulmonary obstruction, cystic fibrosis, clinically evident bronchiectasis, significant alcohol or drug abuse or contraindications to exercise.
5. Patients who have undergone thoracotomy with pulmonary resection.
6. Patients being treated with oral beta-adrenergics or oral corticosteroid medication at unstable doses (i.e., less than six weeks on a stable dose) or at doses in excess of the equivalent of 10 mg of prednisone per day or 20 mg every other day.
7. Patients who regularly use daytime oxygen for more than one hour per day.
8. Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program.
9. Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnea.
10. Pregnant or nursing women.
11. Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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151 participants in 3 patient groups, including a placebo group

Olodaterol (BI 1744) Low

Experimental group

Description:

Low dose inhaled orally once daily from the Respimat inhaler

Treatment:

Drug: Olodaterol (BI 1744)

Drug: Olodaterol (BI 1744)

Drug: Olodaterol (BI 1744) Placebo

Drug: Olodaterol (BI 1744)

Olodaterol (BI 1744) High

Experimental group

Description:

High dose inhaled orally once daily from the Respimat inhaler

Treatment:

Drug: Olodaterol (BI 1744)

Drug: Olodaterol (BI 1744)

Drug: Olodaterol (BI 1744)

Placebo

Placebo Comparator group

Description:

Olodaterol (BI 1744) placebo inhaled once daily from the Respimat inhaler

Treatment:

Drug: Placebo